What are the side effects of Ropinirole (a dopamine agonist)?

Ropinirole Side Effects

Ropinirole has significant side effects including nausea, orthostatic hypotension, sleepiness, headache, and compulsive behaviors, and is not recommended as standard treatment for restless legs syndrome due to its adverse effect profile. 1

Common Side Effects

• Gastrointestinal effects: Nausea and vomiting are among the most frequently reported side effects 1, 2, 3
• Central nervous system effects:
  • Somnolence and drowsiness 1, 2
  • Dizziness 2
  • Headache 1
  • Hallucinations, particularly in older patients 1, 2, 3
  • Sleep disturbances 2
• Cardiovascular effects:
  • Orthostatic hypotension 1, 2
  • Changes in heart rate (decrease or increase) 2
  • Leg edema 3
• Fatigue and weakness 2, 3

Serious Side Effects

• Falling asleep during normal activities: Patients may suddenly fall asleep without warning while performing daily activities including driving 2
• Fainting: May occur with decreased heart rate, especially when starting treatment or increasing dose 2
• Compulsive behaviors: Unusual urges including gambling, increased sexual urges, uncontrollable shopping, and compulsive eating 1, 2
• Psychotic-like behavior: Including hallucinations, confusion, excessive suspicion, aggressive behavior, agitation, and delusional beliefs 2
• Uncontrolled sudden movements: May cause or worsen dyskinesia 2
• Withdrawal symptoms: When dose is reduced or discontinued, patients may experience fever, confusion, severe muscle stiffness, pain, insomnia, apathy, depression, and anxiety 2

Special Considerations for Older Patients

• Older patients are at particular risk for orthostasis and drug interactions 1
• Hallucinations are more common in elderly patients 1, 2
• Cognitive effects may be more pronounced in older adults 1

Augmentation Phenomenon

• Augmentation is characterized by worsening and earlier onset of symptoms in patients initially controlled on medication 1
• Typical presentations include:
  • Earlier symptom onset during the day 1
  • Increased symptom intensity 1
  • Spread of symptoms to other body parts (e.g., from calves to thighs) 1
  • Rebound effects in the morning or latter part of the night 4

Clinical Recommendations

• The American Academy of Sleep Medicine suggests against the standard use of ropinirole for restless legs syndrome (conditional recommendation, moderate certainty of evidence) 1
• If used for RLS, ropinirole should be reserved for patients who prioritize short-term symptom reduction over concerns about long-term adverse effects 1
• Starting dose for RLS is 0.25 mg orally 1-3 hours before bedtime 1
• Dose can be increased after 2-3 days to 0.5 mg, and to 1 mg after 7 days 1
• Titration should proceed slowly with weekly 0.5 mg increments to a maximum of 4 mg at week 7 if needed 1
• Do not suddenly stop taking ropinirole without medical supervision due to risk of withdrawal symptoms 2
• Take with or without food 2

Risk Mitigation

• Monitor for orthostatic hypotension, especially when initiating therapy or increasing dose 1, 2
• Screen for and educate patients about potential compulsive behaviors 2
• Caution patients about driving or operating machinery due to risk of sudden sleep onset 2
• Consider drug interactions with other medications 1
• Avoid alcohol as it may increase drowsiness 2

Contraindications

• Allergy to ropinirole or any ingredients in the formulation 2
• Use caution in patients with significant cardiovascular disease 2
• Not recommended during pregnancy or breastfeeding due to insufficient safety data 2